After the long weekend, my batteries have been refilled and I'm ready for whatever the market throws at us.
This has been posted recently, but I want to post it again and listen to it a few more times.
In summary - all our indications are still in play
This is great for my confirmation bias, but the SP won't move much until one of the following is ticked off:
- Partnership $$$
- FDA approval
Bring on CLPB!!!
GL guys
https://www.lsegissuerservices.com/spark/Mesoblast/events/7fec731a-4a40-4c41-af2d-23e1dd7fce2d
@LeftYahoo summed it up best here...
"Great interview, thanks for posting. In terms of CHF, CEO Sylviu Itescu pretty much confirms many of the points already made here and and on HC, but there are some interesting fine points. Rex-L is a breakthrough product and they will be partnering it with big pharma or big biotech. That sounds definite. He did confirm what I had posted below: that indeed a pathway to licensure may exist without doing another phase 3 trial - due to existing work in end-stage CHF with RMAT designation and previous agreement with the FDA that any trial showing a mortality benefit might allow licensure for the orphan indication (gi bleeding in LVAD patients). Further discussions with the FDA are pending. All those who have said another phase 3 will definitely be needed should retract your posts - there are many of them. The other fine point of interest with respect to CHF is the definite correlation between elevated CRP levels and risk of 3-point MACEvents. Such that they will be looking to expand the indication beyond CHF to other inflammatory conditions that predispose to atherosclerosis (he mentioned diabetes). This is huge. As I've said before, look for publication of this research in a major medical journal such as NEJM or Lancet. And look for a major partnership to commercialize and develop the product further. REspecting rem-L, a couple of fine points: he confirmed that the FDA had agreed to a single-arm study in children when it began (meaning their "change of heart" to now require a controlled trial in children is inexplicable). SI continues to project an optimistic tone for a favorable outcome on the childhood GvHD indication through the dispute resolution process. He didn't say it, but having Novartis at Mesoblast's side should add gravitas to their presentations. Regarding ARDS he confirmed that during the second half of the current trial the patient population shifted from primarily an inflammatory lung disease where rem-L can shine to more advance fibrotic lung disease in patients 15 years older on average. He continues to project a positive tone with respect to Novartis moving forward with a non-Covid ARDS trial based on results of the current study (and mentioned that decision will generate milestones). He ended the interview with a nice zinger to the effect: "in the illnesses we're focused on, CHF, CLBP AND ARDS, we have NO competitors". Trust everyone is chuckling at his enduring sense of humor."
(20min delay)